Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)

• Status: Completed
• Trial end date: 2016-04-28
• Target enrollment: 0
• Participant gender: Female

Summary

This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel; Pertuzumab; Topotecan

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, and/or fallopian tube cancer that is platinum-resistant or refractory

• Low Human epidermal growth factor receptor (HER) 3 messenger ribonucleic acid (mRNA) expression

• At least one measurable and/or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version (V) 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

• Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)

• Negative serum pregnancy test in women of childbearing potential

• Women of childbearing potential must agree to use effective contraception as defined by protocol during and for at least 6 months post study treatment

Exclusion Criteria:

• Non-epithelial tumors

• Ovarian tumors with low malignant potential (borderline tumors)

• History of other malignancy of prognostic relevance within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma, or tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the breast

• Previous treatment with more than 2 chemotherapy regimens

• Any prior radiotherapy to the pelvis or abdomen

• History or evidence on physical/neurological examination of central nervous system disease unrelated to cancer (uncontrolled seizures), unless adequately treated with standard medical therapy

• Pre-existing peripheral neuropathy >/= common toxicity criteria (CTC) grade 2 (applicable for paclitaxel cohort only)

• Inadequate organ function

• Uncontrolled hypertension or clinically significant cardiovascular disease

• Current known infection with human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV), or hepatitis C virus (HCV)

• Current chronic daily treatment with corticosteroids (>/= 10 mg per day of methylprednisolone or equivalent), excluding inhaled steroids

• History of receiving any investigational treatment within 28 days prior to first study drug administration

• For Part 2 of the trial: prior enrollment into Part 1 of the trial

• Concurrent participation in any therapeutic clinical trial